Sorafenib Increases Survival in Patients with Advanced Liver Cancer

BARCELONA, Spain—The oral multikinase inhibitor sorafenib (Nexavar) offers a significant survival benefit in patients with late-stage hepatocellular carcinoma, investigators reported at the European Cancer Conference.

In the phase 3 Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol trial, sorafenib treatment was associated with a 44% increase in overall survival and a 73% prolongation in time to symptomatic progression.

"Sorafenib is the first systemic therapy to prolong survival in this difficult-to-treat population, in whom existing systemic therapies confer no proven survival benefit," said lead investigator Josep Llovet, MD, director of Hepatocellular Research at Mount Sinai School of Medicine, New York City.

Conducted at more than 100 sites worldwide, the study included 602 patients with advanced hepatocellular carcinoma and no previous systemic therapy; the patients were randomized to 6 months of treatment with sorafenib (400 mg twice daily) or to placebo. The primary efficacy end points were overall survival and time to symptomatic progression.

The trial was halted early after a planned interim analysis demonstrated sorafenib's significant superiority over placebo in the primary efficacy end points of overall survival and time to symptomatic progression. The median overall survival was 46 weeks in the sorafenib group compared with 34 weeks in the placebo group; median time to progression was 24 and 12 weeks, respectively. Sorafenib was well tolerated.

"Based on our results, sorafenib is the new reference standard for systemic therapy of patients with hepatocellular cancer," Dr Llovet said.

Hepatocellular carcinoma is the fifth most common malignancy worldwide, and about 19,000 new cases are diagnosed in the United States each year. Nearly half of all cases are detected at an advanced stage.

Aclidinium Bromide Shows Promise in Lung Disease

STOCKHOLM, Sweden—The investigational agent aclidinium bromide (Forest) provides important improvements in key lung function measures in patients with chronic obstructive pulmonary disease (COPD), according to a phase 2 clinical trial presented at the European Respiratory Society meeting.

Aclidinium is a long-acting, inhaled anticholinergic bronchodilator that is being tested for once-daily maintenance treatment of COPD.

Guy Joos, MD, professor of medicine at the University of Ghent, Belgium, reported findings in 17 patients with moderate-to-severe COPD who received 1 of 3 doses of aclidinium or placebo administered via dry-powder inhaler.

A single inhalation of aclidinium at all 3 doses tested produced a significant bronchodilatory response; mean forced expiratory volume (FEV) in 1 second and FEV in 2 seconds values were significantly increased over the 24-hour study period compared with placebo.

The bronchodilatory effects of aclidinium were observed as early as 15 minutes postdose and were sustained for at least 24 hours. Aclidinium was well tolerated, and no patient withdrew from the study because of adverse events.

"Given the high morbidity and mortality associated with COPD and the differences in individual patients' response to therapy, development of additional treatment options is warranted," Dr Joos said.

Bivalirudin as Monotherapy Reduces Early Risk of Bleeding in Patients with ACS

STOCKHOLM, Sweden—Patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) who receive the thrombin inhibitor bivalirudin (Angiomax) alone have a 50% lower risk of major bleeding at 30 days than patients treated with unfractionated heparin/enoxaparin (Lovenox) plus a glycoprotein (GP) IIb/IIIa inhibitor, according to data released at the European Society of Cardiology Congress.

Harvey White, DSc, director of coronary care and cardiovascular research at Green Lane Hospital, Auckland, New Zealand, reported results in 7789 moderate- to high-risk patients with ACS who were assigned to unfractionated heparin or enoxaparin plus a GP IIb/IIIa inhibitor, bivalirudin plus a GP IIb/IIIa inhibit or, or bivalirudin monotherapy with subsequent PCI as part of the Acute Catheterization and Urgent Intervention Triage Strategy trial. Major bleeding was significantly reduced at 30 days in the bivalirudin monotherapy arm, but the 1-year mortality rate was not significantly different in the 2 arms.

Switching patients from previous treatment with unfractionated heparin or enoxaparin to bivalirudin monotherapy was safe and effective, enabling patients to achieve an approximate 50% reduction in major bleeding while maintaining protection against adverse ischemic outcomes and death at 1 year.

Hospital stay was 5 days for patients with a major bleed unrelated to a bypass surgery and 3 days in patients who did not bleed. "Our results suggest that bivalirudin monotherapy should be the preferred adjunctive antithrombotic strategy in moderate- and high-risk ACS patients undergoing PCI," Dr White said.

Eating Disorders a Hazard of First Year in College for Females

ALBERTA, Canada—The challenges of moving away from home and adjusting to a new environment seem to increase the risk of eating disorders in young women facing their first year of college, according to a new study (J Youth & Adolescence. 2007;36:904-911).

An analysis of 14-day, web-based diary of the health behaviors maintained by 101 full-time college female students during the first 3 months of their freshman year.

Those who lived away from home were 3 times more likely to report binge-eating episodes than female students who lived with their parents while in college. And those who reported being dissatisfied with their bodies were 3 times as likely to have binge-eating episodes during their first year of college.

Compiled by our Paris-based correspondent Jill Stein.